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Device-Makers Need To Open Up More On Cybersecurity In Pre-Market, Draft Guidance Says

A new update to the pre-market cybersecurity guidance issued four years ago reflects how US FDA's thinking on the issue has evolved, as more cases of device vulnerabilities have surfaced. Among the key updates are recommendations for sponsors to submit a cybersecurity "bill of materials" in product labeling to better coordinate with end-users and to use a two-tiered risk management approach.

Maksim Kabakou/Shutterstock.com

US FDA has developed a two-tiered system for assessing the cybersecurity risk level of a medical device in a new draft guidance intended to update a 2014 document. The new draft, addressing pre-market cybersecurity recommendations for device companies, also directs device-makers include a cybersecurity "bill of materials" and makes other labeling recommendations.

The agency released the draft guidance this week after officials have been signaling plans for the updates for the past several months. At 24 pages, it is significantly more detailed compared to the nine-page

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